Regulatory Actions
Ranbaxy Receives Tentative FDA Approval To Manufacture And Market Zolpidem Tablets
Published in Medical Letter on the CDC and FDA, April 8th, 2007
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien(R) Tablets 5mg and 10mg of Sanofi Aventis US, LLC. The products will be manufactured at the company's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey. Total annual market sales for Zolpidem Tartrate Tablets were USD 2.12 Bn (IMS: Dec. 2006).
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